Job SummaryThe Senior Manager, Regulatory Affairs is a senior individual contributor responsible for regulatory decision making and strategy for complex or high-risk products, regions, or regulatory topics. Approves regulatory strategies developed by Managers and below, guides execution, and acts as the senior Regulatory lead on cross functional teams. Accountable for lifecycle compliance (pre and post market) and escalation of regulatory risk. Provides cross team coaching/mentoring and technical leadership.
*This position requires working onsite in Lake Zurich 3 days per week; remaining days may be worked remotely.
*This position is not eligible for visa sponsorship either now or in the future.
• Salary Range: $160,000-170,000.
• Position is eligible to participate in an annual bonus plan with a target of 14% of the base salary.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Responsibilities- Own regulatory decision-making and strategy for assigned product lines, projects, regions, or regulatory initiatives involving significant complexity or regulatory risk
- Prepare, author, coordinate, or provide senior technical oversight for U.S. and/or international submissions (e.g., 510(k)/NDA Supplements, as applicable), involving complex, high-risk, or strategically significant regulatory issues, including responses to regulatory agency questions.
- Approve regulatory strategies developed by Managers and below.
- Represent Regulatory as the senior Regulatory Affairs lead on assigned product/project teams and ensure regulatory strategies worldwide align with business objectives.
- Maintain appropriate communications within Regulatory to align on technical regulatory positions and support escalation decisions, as well as across other functions at the project team level to ensure consistent execution across affected project teams.
- Provide strategic and technical input to support product development, project plans, and other business decisions, as needed.
- Monitor evolving regulatory requirements (including import/export requirements as applicable); assess potential impact on assigned products/projects or technologies and ensure compliance where applicable.
- Review and approve product labeling and advertising/promotional materials for compliance to applicable regulatory requirements.
- Support regulatory activities for government tenders/initiatives, including obtaining and maintaining professional certifications (if required).
- Ensure post-market regulatory compliance (e.g., annual reports, PADERs, PSURs, PMS/PMCF reports) are maintained, where applicable.
- Lead complex Health Authority interactions (e.g. meetings, negotiations, responses); develop and maintain effective relationships with regulatory agencies.
- Mentor and train other regulatory team members as appropriate.
Job Requirements - Bachelor's Degree with 8+ years of experience in a regulatory function.
- Strong technical, regulatory, and problem-solving skills, including an understanding of device and/or drug regulatory requirements, their foundation and submission processes.
- Demonstrated experience with providing and executing complex regulatory strategies and/or managing novel regulatory challenges.
- Advanced interpersonal skills and a demonstrated ability to manage conflict situations and influence stakeholders.
- Proven effective collaboration with regulatory agencies.
- Experience with infusion systems, transfusion technologies, cellular therapies, or drugs preferred.
- The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
